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- 2013014696 contributor B12721560.
- 2013014696 created "c2014.".
- 2013014696 date "2014".
- 2013014696 date "c2014.".
- 2013014696 dateCopyrighted "c2014.".
- 2013014696 description "Active pharmaceutical ingredient / Edward M. Cohen, Steven Sutherland -- Analytical methods development and methods validation for solid oral dosage forms / Quanyin Gao, Dilip R. Sanvordeker -- Experimental formulation development / Isadore Kanfer ... [et al.] -- Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed ... [et al.] -- Drug stability / Pranab K. Bhattacharyya -- Quality control and quality assurance / Loren Gelber -- Drug product performance, in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ANDA regulatory approval process / Timothy W. Ames, Aaron Sigler -- Bioequivalence and drug product assessment, in vivo / Barbara M. Davit, Dale P, Conner -- Statistical considerations for establishing bioequivalence / Charles Bon, Sanford Bolton -- Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- Post-approval changes and post-marketing surveillance / Lorien Armour, Leon Shargel -- United States Pharmacopeia-National Formulary : its history, organization, and role in harmonization / William Brown, Margareth R.C. Marques -- Legal and legislative hurdles to generic drug development, approval and marketing / Arthur T. Tsien.".
- 2013014696 description "Includes bibliographical references and index.".
- 2013014696 extent "xii, 385 p. :".
- 2013014696 identifier "9781420086355 (hbk. : alk. paper)".
- 2013014696 identifier "9781420086362 (eBook)".
- 2013014696 isPartOf "Drugs and the pharmaceutical sciences ; 129".
- 2013014696 issued "2014".
- 2013014696 issued "c2014.".
- 2013014696 language "eng".
- 2013014696 publisher "Boca Raton, FL : CRC Press/Taylor & Francis Group,".
- 2013014696 subject "615/.19 23".
- 2013014696 subject "Chemistry, Pharmaceutical standards.".
- 2013014696 subject "Drug Approval.".
- 2013014696 subject "Drugs, Generic standards.".
- 2013014696 subject "Generic drugs.".
- 2013014696 subject "QV 771".
- 2013014696 subject "RS55.2 .G455 2014".
- 2013014696 subject "Solid dosage forms.".
- 2013014696 subject "Tablets.".
- 2013014696 subject "W1 DR893B v.129 2014".
- 2013014696 tableOfContents "Active pharmaceutical ingredient / Edward M. Cohen, Steven Sutherland -- Analytical methods development and methods validation for solid oral dosage forms / Quanyin Gao, Dilip R. Sanvordeker -- Experimental formulation development / Isadore Kanfer ... [et al.] -- Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed ... [et al.] -- Drug stability / Pranab K. Bhattacharyya -- Quality control and quality assurance / Loren Gelber -- Drug product performance, in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ANDA regulatory approval process / Timothy W. Ames, Aaron Sigler -- Bioequivalence and drug product assessment, in vivo / Barbara M. Davit, Dale P, Conner -- Statistical considerations for establishing bioequivalence / Charles Bon, Sanford Bolton -- Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- Post-approval changes and post-marketing surveillance / Lorien Armour, Leon Shargel -- United States Pharmacopeia-National Formulary : its history, organization, and role in harmonization / William Brown, Margareth R.C. Marques -- Legal and legislative hurdles to generic drug development, approval and marketing / Arthur T. Tsien.".
- 2013014696 title "Generic drug product development : solid oral dosage forms / edited by Leon Shargel, Isadore Kanfer.".
- 2013014696 type "text".